FDA Adverse Event
Malfunction
Summary report: N
HORIZON MEDICAL PRODUCTS INC.
MDR report key: 196640
·
Received November 13, 1998
Report
- Report Number
- 196640
- Event Type
- Malfunction
- Date Received
- November 13, 1998
- Date of Event
- October 16, 1998
- Report Date
- October 30, 1998
- Manufacturer
- HORIZON MEDICAL PRODUCTS
- Product Code
- LJT
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- KS, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PORT A CATH (LIFEPORT) WAS LEAKING. NO TENDERNESS. NO ERYTHEMA. NO EDEMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HORIZON MEDICAL PRODUCTS INC. Implant | LIFEPORT | LJT | HORIZON MEDICAL PRODUCTS | * | 14540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |